Malignant Pleural EffusionPhase 1NCT04039126
Comparison of the Effectiveness of Povidone-Iodine Alone to Povidone-Iodine-Tetracycline Combination
A Phase 1 study testing CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATION and CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE in people with Malignant Pleural Effusion, run by University College Hospital, Ibadan at 1 site in Nigeria.
Trial summary
Title of study: Comparison of the Effectiveness of Povidone-Iodine alone to Povidone-Iodine--Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion. Research design: Prospective Randomized Controlled Clinical Trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATION and CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteNigeria
- Study dates
- 20 Jun 2019to 31 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • All adult patients aged between18- 70 years presenting with pleural effusion in association with a malignant disease.
- Patients with documented malignant pleural effusion ( i.e positive pleural fluid for malignant cells on pleural fluid cytology and/or positive pleural biopsy for malignant tissue).
- Reaccumulation of an effusion after drainage or patients presenting with symptoms related to pleural fluid re-accumulation such as dyspnea, cough and chest pain.
- Patient with full lung re-expansion after thoracostomy tube insertion and drainage of effusion.
Who cannot join
- • Patients with known hypersensitivity either to Povidone-iodine and/or Tetracycline
- Failure to achieve full lung re-expansion following drainage of the effusion within 48hrs
- Locoregional radiotherapy to the effusion side.
- Loculated pleural effusion
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Nigeria1 site, 1 recruiting
- Recruiting
University College Hospital,
Ibadan, Oyo State, 200212
Jibril Khalil, MBBS, +2348036602929, jibril.khalil@gmail.com
About this study
Official title: Comparison of the Effectiveness of Povidone-Iodine Alone to Povidone-Iodine-Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion
Title of study: Comparison of the Effectiveness of Povidone-Iodine alone to Povidone-Iodine--Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion.
Research design: Prospective Randomized Controlled Clinical Trial. Background: Malignant pleural effusion (MPE) is commonly encountered in clinical practice among patients with malignancy. In addition to its association with major morbidities, it also poses a high risk of recurrence following drainage. Chemical pleurodesis is often required to achieve pleural adhesion and obliteration of the pleural space to prevent such recurrence. Several agents are in common use for chemical pleurodesis with mixed effectiveness.
Read the detailed description
STRUCTURED SUMMARY Title of study: Comparison of the Effectiveness of Povidone-Iodine alone to Povidone-Iodine--Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion.
Research design: Prospective Randomized Controlled Clinical Trial. Background: Malignant pleural effusion (MPE) is commonly encountered in clinical practice among patients with malignancy. In addition to its association with major morbidities, it also poses a high risk of recurrence following drainage. Chemical pleurodesis is often required to achieve pleural adhesion and obliteration of the pleural space to prevent such recurrence. Several agents are in common use for chemical pleurodesis with mixed effectiveness.
Methodology: 62 consenting but blinded patients with clinical features of MPE who are undergoing pleural drainage and have fulfilled the criteria for chemical pleurodesis will be grouped by block balanced randomization into two equal groups- A and B. All the patients in Group A (Test) will have pleurodesis done with a solution combining 1 gram of sterile Tetracycline powder with 20mls of 10% Povidone-iodinemixed with 10mls of 1% xylocaine (for local intrapleural anesthesia) and 30mls of sterile water for injection instilled through the chest tube into the pleural space, while allpatients in Group B (Active control) will have 20mls of 10% Povidone-iodine mixed with 10mls of 1% xylocaine and 30mls of sterile water for injection. Drainage and radiographic parameters will be collected prior to chest tube removal and during outpatient follow-up to assess the effectiveness of pleurodesis in each group.
Objectives: To determine if combining tetracycline with 10% Povidone-iodine increases its effectiveness in pleurodesis for MPE.
Principal Exposure:Chemical pleurodesis with 10% Povidone-Iodine or combination of 10% Povidone-iodine-Tetracycline (1 gram).
Outcome variables: The primary outcome variable is the success of the pleurodesis in controlling MPE at 1month and 3 months follow-up. Success of pleurodesis classified as been Complete pleurosesis or Failed pleurodesis. The secondary outcome variables are: post-procedure complications of pain, hypotension,fever and occurrence of empyema thoracis, duration of thoracostomy tube retention post-pleurodesis, need for repeat of the procedure Keywords: Malignant Pleural Effusion, Chemical Pleurodesis, 10% Povidone-iodine, Tetracycline, Effectiveness
- Conditions
- Malignant Pleural Effusion
- Being tested
- CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATION, CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE
- Keywords
- MALIGNANT PLEURAL EFFUSSION
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATIONDrug
Also called PLEURODESIS
Pleurodesis is the obliteration of the pleural cavity by inducing adhesions of the visceral and parietal pleural layers, mostly used in patients with pleural effusions, pneumothorax (18). The use of pleurodesis to induce pleural symphysis between the pleural layers dates backs to the beginning of the 20th century by Benthune(19) and has continued to evolve with different Thoracic surgeons and researchers still looking for the ideal pleurodesis agent.
CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONEDrug
Also called PLEURODESE
20mls of 10% povidone-iodine (Wosan Solution Povidone-Iodine Usp 10%, Jawa International Limited) is mixed with 10mls of 1% xylocaine and 30mls of water for injection added to the mixture, making also a total volume of 60mls of the the single pleurodesis agents alone, which will be instilled into the pleural space via the closed thoracotomy tube.
| Study group | Role | What they receive |
|---|---|---|
| PATIENTS WITH MALIGNANT PLEURAL EFFUSION | Experimental | PARTICIPANTS WITH MALIGNANT PLEURAL EFFUSIONS REQUIRING PLEURODESIS, COMBINATION OD POVIDONE IODOONE-TETRCYCLINE TO BE USED. Receives: Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATION; Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE |
| PATEINT WITH MALIGANT PLEURAL EFFUSION REQUIRNG PLEURODESIS | Active comparator | TO USE POVIDONE IODINE ALONE IN THIS GROUP Receives: Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of pleurodesis
classified as either a Complete Pleurodesis or Failed Pleurodesis. Complete pleurodesis defined as absence of pleural fluid re-accumulation on a chest radiograph at 1 and 3 months post-chemical pleurodesis, while Failed pleurodesis defined as pleural fluid re-accumulation requiring additional tube thoracostomy drainage before or at 1- 3 month follow up.
Measured: 1 AND 3 MONTH AFTER PLEURODESIS
Secondary outcomes (1)
Adverse Effects from the chemical pleurodesis agent used
Adverse effects which are Post-procedure Pain, Hypotension, Fever and development of Empyema Thoracis following pleurodesis.
Measured: immediate post procedure( 30minutes and 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start20 Jun 2019
- Primary completionDec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Hospital, Ibadan
- Sponsor type
- University, hospital or other
- Collaborators
- West African College of Surgeons
- Responsible party
- Principal investigator, Dr. Jibril Khalil, University College Hospital, Ibadan
- Investigators
- catherine Falade, Prof., Study chair, institute for advanced medical research and training, UI, IBADAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039126
- Sponsor's protocol ID
- UI/EC/19/0177
- Status last verified
- Nov 2020
- First submitted
- 27 Jul 2019
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: proforma of the study, with theinformation gathered during the study.
Publications
Psallidas I, Kalomenidis I, Porcel JM, Robinson BW, Stathopoulos GT. Malignant pleural effusion: from bench to bedside. Eur Respir Rev. 2016 Jun;25(140):189-98. doi: 10.1183/16000617.0019-2016.
PubMed 27246596Antony VB, Loddenkemper R, Astoul P, Boutin C, Goldstraw P, Hott J, Rodriguez Panadero F, Sahn SA. Management of malignant pleural effusions. Eur Respir J. 2001 Aug;18(2):402-19. doi: 10.1183/09031936.01.00225601. No abstract available.
PubMed 11529302Chernow B, Sahn SA. Carcinomatous involvement of the pleura: an analysis of 96 patients. Am J Med. 1977 Nov;63(5):695-702. doi: 10.1016/0002-9343(77)90154-1. No abstract available.
PubMed 930945
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Povidone-Iodine Alone to Povidone-Iodine-Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT04039126
- Acronym / sponsor ID
- UI/EC/19/0177
- Conditions
- Malignant Pleural Effusion
- Keywords
- MALIGNANT PLEURAL EFFUSSION
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University College Hospital, IbadanUniversity, hospital or other
- Collaborators
- West African College of Surgeons
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title of study: Comparison of the Effectiveness of Povidone-Iodine alone to Povidone-Iodine--Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion.
Research design: Prospective Randomized Controlled Clinical Trial. Background: Malignant pleural effusion (MPE) is commonly encountered in clinical practice among patients with malignancy. In addition to its association with major morbidities, it also poses a high risk of recurrence following drainage. Chemical pleurodesis is often required to achieve pleural adhesion and obliteration of the pleural space to prevent such recurrence. Several agents are in common use for chemical pleurodesis with mixed effectiveness.
Detailed description
STRUCTURED SUMMARY Title of study: Comparison of the Effectiveness of Povidone-Iodine alone to Povidone-Iodine--Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion.
Research design: Prospective Randomized Controlled Clinical Trial. Background: Malignant pleural effusion (MPE) is commonly encountered in clinical practice among patients with malignancy. In addition to its association with major morbidities, it also poses a high risk of recurrence following drainage. Chemical pleurodesis is often required to achieve pleural adhesion and obliteration of the pleural space to prevent such recurrence. Several agents are in common use for chemical pleurodesis with mixed effectiveness.
Methodology: 62 consenting but blinded patients with clinical features of MPE who are undergoing pleural drainage and have fulfilled the criteria for chemical pleurodesis will be grouped by block balanced randomization into two equal groups- A and B. All the patients in Group A (Test) will have pleurodesis done with a solution combining 1 gram of sterile Tetracycline powder with 20mls of 10% Povidone-iodinemixed with 10mls of 1% xylocaine (for local intrapleural anesthesia) and 30mls of sterile water for injection instilled through the chest tube into the pleural space, while allpatients in Group B (Active control) will have 20mls of 10% Povidone-iodine mixed with 10mls of 1% xylocaine and 30mls of sterile water for injection. Drainage and radiographic parameters will be collected prior to chest tube removal and during outpatient follow-up to assess the effectiveness of pleurodesis in each group.
Objectives: To determine if combining tetracycline with 10% Povidone-iodine increases its effectiveness in pleurodesis for MPE.
Principal Exposure:Chemical pleurodesis with 10% Povidone-Iodine or combination of 10% Povidone-iodine-Tetracycline (1 gram).
Outcome variables: The primary outcome variable is the success of the pleurodesis in controlling MPE at 1month and 3 months follow-up. Success of pleurodesis classified as been Complete pleurosesis or Failed pleurodesis. The secondary outcome variables are: post-procedure complications of pain, hypotension,fever and occurrence of empyema thoracis, duration of thoracostomy tube retention post-pleurodesis, need for repeat of the procedure Keywords: Malignant Pleural Effusion, Chemical Pleurodesis, 10% Povidone-iodine, Tetracycline, Effectiveness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATIENTS WITH MALIGNANT PLEURAL EFFUSION | Experimental | Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATION, Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONEPARTICIPANTS WITH MALIGNANT PLEURAL EFFUSIONS REQUIRING PLEURODESIS, COMBINATION OD POVIDONE IODOONE-TETRCYCLINE TO BE USED. |
| PATEINT WITH MALIGANT PLEURAL EFFUSION REQUIRNG PLEURODESIS | Active comparator | Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONETO USE POVIDONE IODINE ALONE IN THIS GROUP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • All adult patients aged between18- 70 years presenting with pleural effusion in association with a malignant disease.
Key exclusion criteria (5 listed)
- • Patients with known hypersensitivity either to Povidone-iodine and/or Tetracycline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATIONAlso: PLEURODESISPleurodesis is the obliteration of the pleural cavity by inducing adhesions of the visceral and parietal pleural layers, mostly used in patients with pleural effusions, pneumothorax (18). The use of pleurodesis to induce pleural symphysis between the pleural layers dates backs to the beginning of the 20th century by Benthune(19) and has continued to evolve with different Thoracic surgeons and researchers still looking for the ideal pleurodesis agent. | Drug | PATIENTS WITH MALIGNANT PLEURAL EFFUSION |
| CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONEAlso: PLEURODESE20mls of 10% povidone-iodine (Wosan Solution Povidone-Iodine Usp 10%, Jawa International Limited) is mixed with 10mls of 1% xylocaine and 30mls of water for injection added to the mixture, making also a total volume of 60mls of the the single pleurodesis agents alone, which will be instilled into the pleural space via the closed thoracotomy tube. | Drug | PATEINT WITH MALIGANT PLEURAL EFFUSION REQUIRNG PLEURODESIS, PATIENTS WITH MALIGNANT PLEURAL EFFUSION |
Primary outcome
Success of pleurodesis
Time frame: 1 AND 3 MONTH AFTER PLEURODESIS
classified as either a Complete Pleurodesis or Failed Pleurodesis. Complete pleurodesis defined as absence of pleural fluid re-accumulation on a chest radiograph at 1 and 3 months post-chemical pleurodesis, while Failed pleurodesis defined as pleural fluid re-accumulation requiring additional tube thoracostomy drainage before or at 1- 3 month follow up.
1 secondary outcome
Adverse Effects from the chemical pleurodesis agent used
Time frame: immediate post procedure( 30minutes and 1 hour)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Background: PubMed 27246596Psallidas I, Kalomenidis I, Porcel JM, Robinson BW, Stathopoulos GT. Malignant pleural effusion: from bench to bedside. Eur Respir Rev. 2016 Jun;25(140):189-98. doi: 10.1183/16000617.0019-2016.
- Background: PubMed 11529302Antony VB, Loddenkemper R, Astoul P, Boutin C, Goldstraw P, Hott J, Rodriguez Panadero F, Sahn SA. Management of malignant pleural effusions. Eur Respir J. 2001 Aug;18(2):402-19. doi: 10.1183/09031936.01.00225601. No abstract available.
- Background: PubMed 930945Chernow B, Sahn SA. Carcinomatous involvement of the pleura: an analysis of 96 patients. Am J Med. 1977 Nov;63(5):695-702. doi: 10.1016/0002-9343(77)90154-1. No abstract available.
- Individual participant dataSharing planned: Yes. proforma of the study, with theinformation gathered during the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
catherine Falade, Prof. study chair
institute for advanced medical research and training, UI, IBADAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATION and CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE in people with Malignant Pleural Effusion, run by University College Hospital, Ibadan at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jibril Khalil, MMBS (+2348036602929, jibril.khalil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of pleurodesis (time frame: 1 AND 3 MONTH AFTER PLEURODESIS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04039126, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.